Packaged catheter assembly and method of manufacturing same

Abstract

A catheter assembly that has a catheter tube coupled to a funnel, and a handling sleeve. The handling sleeve is formed from a flexible film material and is releasably attached to the funnel. One embodiment of the invention provides a method of processing a catheter assembly; the method comprising: engaging the funnel of a catheter assembly comprising a catheter tube and a funnel, such that the catheter tube hangs down from the funnel; and releasably attaching the handling sleeve to the funnel.

1 . A method of processing a catheter assembly comprising a catheter tube coupled to a funnel and a handling sleeve releasably attached to the funnel; the method comprising engaging the funnel, such that the catheter tube hangs down from the funnel. 
     
     
         2 . A method according to  claim 1  comprising engaging the funnel, such that the catheter tube hangs down from the funnel and releasably attaching the handling sleeve thereto. 
     
     
         3 . A method according to  claim 1 or 2  wherein the handling sleeve is attached via a sleeve-attachment portion. 
     
     
         4 . A method according to  any preceding claim  wherein the handling sleeve is formed of a flexible film. 
     
     
         5 . A method according to  claim 3  wherein the handling sleeve and the sleeve attachment portion are formed of a flexible film and wherein a point of weakness is provided between the handling sleeve and the sleeve-attachment portion. 
     
     
         6 . A method according to  any preceding claim  wherein the handling sleeve is a short sleeve which extends extend along less than 50% of the distance to the tip of the catheter tube, whereby a distance of at least 50% from the tip of the catheter towards the funnel is exposed. 
     
     
         7 . A method according to  any preceding claim  comprising engaging the funnel with processing rails. 
     
     
         8 . A method according to  claim 7  comprising suspending the funnel from suspension means, wherein the suspension means are engaged with the processing rails. 
     
     
         9 . A method according to  any preceding claim  comprising separating and orienting a plurality of catheters in bulk, then picking a catheter, the method comprising orienting the catheter assemblies vertically. 
     
     
         10 . A method according to  any preceding claim  comprising advancing a catheter assembly along rails to a sheathing station and attaching the handling sleeve to the funnel in the sheathing station. 
     
     
         11 . A method according to  claim 10  comprising wrapping a sheet of film material around the catheter tube and joining opposing elongate edges of the sheet to form the handling sleeve, or sandwiching the catheter tube between two sheets of film material and joining the two sheets along two elongate edges of each sheet to form the handling sleeve. 
     
     
         12 . A method according to  claim 11  wherein the or each sheet of film material is provided with a point of weakness extending perpendicular to their elongate edges, such that formation of the handling sleeve can simultaneously form a sleeve attachment portion, separated from the handling sleeve by the point of weakness. 
     
     
         13 . A method according to  claim 5  or any of  claims 6 to 12  when dependent on  claim 5 , comprising permanently attaching the sleeve-attachment portion to the funnel by welding or gluing, wherein the handling sleeve is releaseably attached to the sleeve attachment portion that is permanently attached to the funnel. 
     
     
         14 . A method according to  claim 5  or any of  claims 6 to 12  when dependent on  claim 5  wherein the handling sleeve of the sleeve is releaseably attached to the sleeve-attachment portion that is permanently attached to the funnel by means of a frangible connection, the frangible connection formed by welding the sleeve to the funnel, such that the region where the sleeve is welded to the funnel remains permanently attached to the funnel forming a sleeve attachment portion, but the remainder of the sleeve breaks away from the welded region forming the handling sleeve. 
     
     
         15 . A method according to  claim 1, 2  or any one of  claims 6 to 11  comprising releaseably attaching the entire handling sleeve to the funnel, such that the entire sleeve can be released from the funnel, without leaving any portion attached. 
     
     
         16 . A method according to  any preceding claim  comprising reorienting the catheter, after releaseably attaching the handling sleeve from a vertical configuration to a horizontal configuration. 
     
     
         17 . A method according to  claim 16  comprising coiling the catheter, with the catheter in the horizontal configuration, and arranging the coiled catheter on a carrier. 
     
     
         18 . A method according to  claim 17  comprising introducing the coiled catheter and a fluid reservoir into a pouch on a carrier; wherein the coiled catheter is introduced through a side or end that is opposite to a side intended to be opened, which is provided with an opening mechanism and resealing means. 
     
     
         19 . A method according to  claim 18  comprising sealing the pouch after introducing the coiled catheter and the fluid reservoir; and forming a join between the two walls of the pouch, such that the join and an internal base of the peripheral seal may define a channel to be filled with fluid prior to withdrawal of the catheter from the pouch, in use. 
     
     
         20 . A catheter assembly comprising a catheter tube coupled to a funnel, and a handling sleeve; wherein the handling sleeve is formed from a flexible film material and is releasably attached to the funnel. 
     
     
         21 . A catheter assembly according to  claim 20  wherein the handling sleeve is a short sleeve that, when attached, extends along less than 70% of the distance to the tip of the catheter tube, whereby a distance of at least 30% from the tip of the catheter towards the funnel is exposed. 
     
     
         22 . A catheter according to  claim 20 or 21  wherein the handling sleeve is irreversibly detachable from the funnel and wherein the handling sleeve is movable along the length of the catheter. 
     
     
         23 . A catheter according to  claim 20 or 21  wherein the handling sleeve is frangibly attached via a sleeve-attachment portion; the sleeve-attachment portion and the handling sleeve being separable by breaking a point of weakness between the handling sleeve and the sleeve-attachment portion; the point of weakness being provided by a plurality of perforations; the perforations comprising a row of holes extending around the circumference of the handling sleeve; and each hole forming the perforations being a slit. 
     
     
         24 . A catheter assembly according to  claim 23  wherein the separation force required to detach the handling sleeve from the sleeve attachment portion is less than the separation force required to detach the sleeve attachment portion from the funnel. 
     
     
         25 . A catheter assembly according to any of  claims 20 to 24  wherein the catheter assembly is provided in a pouch; the pouch being sealed and sterilized. 
     
     
         26 . A catheter assembly according to any of  claims 20 to 24  wherein the handling sleeve is made from any one or more of: polypropylene (PP), low density polyethylene (LDPE), high density polyethylene (HDPE) or biaxially orientated polypropylene (BOPP).